Congenital Heart DefectsPhase 1/2CPBNCT00921596
Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass (CPB)
A Phase 1/2 study testing cardiac operation with totally endoscopic method in people with Congenital Heart Defects and Heart Valve Diseases, run by Xijing Hospital at 1 site in China.
Trial summary
Conventional cardiac operations are performed with median sternotomy, which is related to great wound, morbidities, longer duration in hospital and most significantly, cosmetic problems. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Congenital Heart Defects, Heart Valve Diseases
- What is being tested?
- cardiac operation with totally endoscopic method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- Jan 2000to Dec 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- congenital heart defects or heart valve diseases require surgical correction
Who cannot join
- Body weight < 10kg
- committed with complex congenital heart defect
- anticipated to perform aortic valve repair or replacement
- anticipated to perform aorta repair or replacement
- committed with Femoral vessel diseases unable to perform femoral cannulation
- refuse to perform totally thoracoscope minimally invasive surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shannxi, 710032
Dinghua Yi, MD, 86-29-84775307, yidinghua@yahoo.com.cn
Zhenxiao Jin, MD, 86-29-84771022, jinzx10262@yahoo.com.cn
About this study
Official title: Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass, a Single Center's Experience
Conventional cardiac operations are performed with median sternotomy, which is related to great wound, morbidities, longer duration in hospital and most significantly, cosmetic problems. The investigators invested a new minimally invasive cardiac operation method totally under video-endoscope and peripheral cardiopulmonary bypass. The investigators' hypothesis is that this new minimally method could provide better cosmetic effects to the patients, and also relate to shorter postoperative hospital stay and better recovery.
- Conditions
- Congenital Heart Defects, Heart Valve Diseases
- Being tested
- cardiac operation with totally endoscopic method
- Keywords
- Surgical Procedures, Cardiac, Minimally Invasive Surgical Procedures, Thoracoscopes, Cardiopulmonary Bypass
- Medical subject headings
- Heart Defects, Congenital, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac operation with totally endoscopic methodProcedure or surgery
Also called thoracoscopic cardiac surgery
Cardiac operations are performed with three keyholes in the right chest wall. Video images are obtained by digital thoracoscope through one hole. Intracardiac lesions are accessed with surgical instruments and repaired through the other two holes. Cardiopulmonary bypass is set up with femoral cannulations. Moderate system hypothermic is applied for the operation. Cardiac arrest is achieved with ascending aorta clamp and cardioplegia solution delivery through aortic root cannulation. After the intracardiac lesions are repaired, aortic clamp is removed, and the heart is reperfused to restore its spontaneous rhythm. After the patients are rewarmed to normal temperature, CPB is discontinued. Femoral cannulations are removed, and surgical wounds are closed.
| Study group | Role | What they receive |
|---|---|---|
| Totally endoscopic cardiac operation | Other | Patients with cardiac diseases undergo cardiac operations with totally endoscopic and cardiopulmonary bypass Receives: Procedure: cardiac operation with totally endoscopic method |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: one year
Secondary outcomes (1)
all cause morbidity
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startJan 2000
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dinghua Yi, MD, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921596
- Sponsor's protocol ID
- xinzangwaike0003
- Acronym
- CPB
- Status last verified
- Jun 2009
- First submitted
- 12 Jun 2009
- Last updated
- 16 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass, a Single Center's Experience
- ClinicalTrials.gov ID
- NCT00921596
- Acronym / sponsor ID
- CPB / xinzangwaike0003
- Conditions
- Congenital Heart Defects, Heart Valve Diseases
- Keywords
- Surgical Procedures, Cardiac, Minimally Invasive Surgical Procedures, Thoracoscopes, Cardiopulmonary Bypass
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conventional cardiac operations are performed with median sternotomy, which is related to great wound, morbidities, longer duration in hospital and most significantly, cosmetic problems. The investigators invested a new minimally invasive cardiac operation method totally under video-endoscope and peripheral cardiopulmonary bypass. The investigators' hypothesis is that this new minimally method could provide better cosmetic effects to the patients, and also relate to shorter postoperative hospital stay and better recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Totally endoscopic cardiac operation | Other | Procedure: cardiac operation with totally endoscopic methodPatients with cardiac diseases undergo cardiac operations with totally endoscopic and cardiopulmonary bypass |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- congenital heart defects or heart valve diseases require surgical correction
Key exclusion criteria (6 listed)
- Body weight < 10kg
- committed with complex congenital heart defect
- anticipated to perform aortic valve repair or replacement
- anticipated to perform aorta repair or replacement
- committed with Femoral vessel diseases unable to perform femoral cannulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac operation with totally endoscopic methodAlso: thoracoscopic cardiac surgeryCardiac operations are performed with three keyholes in the right chest wall. Video images are obtained by digital thoracoscope through one hole. Intracardiac lesions are accessed with surgical instruments and repaired through the other two holes. Cardiopulmonary bypass is set up with femoral cannulations. Moderate system hypothermic is applied for the operation. Cardiac arrest is achieved with ascending aorta clamp and cardioplegia solution delivery through aortic root cannulation. After the intracardiac lesions are repaired, aortic clamp is removed, and the heart is reperfused to restore its spontaneous rhythm. After the patients are rewarmed to normal temperature, CPB is discontinued. Femoral cannulations are removed, and surgical wounds are closed. | Procedure or surgery | Totally endoscopic cardiac operation |
Primary outcome
all cause mortality
Time frame: one year
1 secondary outcome
all cause morbidity
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dinghua Yi, MD study chair
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing cardiac operation with totally endoscopic method in people with Congenital Heart Defects and Heart Valve Diseases, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenxiao Jin, MD (86-29-84771022, jinzx10262@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2009.